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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02005965
Other study ID # CCR2943
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 13, 2007
Est. completion date March 11, 2021

Study information

Verified date September 2018
Source Royal Marsden NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer.

It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.


Description:

The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour < 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 542
Est. completion date March 11, 2021
Est. primary completion date March 11, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to give informed, written consent.

- Adults age 18 or over - male or female.

- Recently diagnosed with biopsy-proven, primary, low rectal cancer.

- No previous therapy for rectal cancer.

Exclusion Criteria:

- Current pregnancy, including ectopic pregnancy.

- Previous pelvic/rectal malignancy (excluding carcinoma in-situ).

- Previous pelvic radiotherapy.

- Previous pelvic floor surgery for faecal incontinence or prolapse.

Study Design


Locations

Country Name City State
Germany Vivantes Klinikum im Friedrichshain Berlin
Germany Krankenhaus Dresden-Friedrichstadt Dresden
Serbia The First Surgical Clinic Belgrade
United Kingdom North Hampshire Hospitals NHS Trust (Basingstoke Hospital) Basingstoke Hampshire
United Kingdom Ulster Hospital Belfast
United Kingdom Bradford Royal Infirmary Bradford West Yorkshire
United Kingdom Princess of Wales Hospital Bridgend Wales
United Kingdom University Hospital of Wales Cardiff Wales
United Kingdom Croydon University Hospital Croydon Surrey
United Kingdom Frimley Park Hospital NHS Foundation Trust Frimley Surrey
United Kingdom West Middlesex University Hospital Isleworth Middlesex
United Kingdom Royal Marsden Hospital London & Surrey
United Kingdom North Manchester General Hospital Manchester
United Kingdom Milton Keynes General Hospital Milton Keynes Buckinghamshire
United Kingdom Salisbury NHS Foundation Trust (Salisbury District Hospital) Salisbury Wiltshire
United Kingdom Stepping Hill Hospital Stockport Cheshire
United Kingdom Weston General Hospital Weston-super-Mare Somerset

Sponsors (2)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust Pelican Cancer Foundation

Countries where clinical trial is conducted

Germany,  Serbia,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the rate of CRM positivity rate in low rectal cancer. 4 years
Primary To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation. 8 years
Secondary To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation. 8 years
Secondary Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE. 8 years
Secondary Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery. 8 years
Secondary Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches. 8 years
Secondary Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates. 8 years
Secondary Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay. 8 years
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